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BXCL501 Film

Phase 2

Bipolar I Disorder | Small molecule | Psychiatry |BioXcel Therapeutics, Inc.|Last Updated: Apr 6, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment33
FDA Designations
BREAKTHROUGH_THERAPYFAST_TRACK
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07116694Assessment of Acute Psychomotor Agitation Measures Associated With Schizophrenia and Bipolar DisorderPHASE2 COMPLETED 33Jun 19, 2025Oct 7, 2025Apr 6, 20265 United States
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Study Endpoints
Primary Endpoints
Informant and Clinician ratings comparison
Before and 2 hours after the intervention

The aim of the study is to assess the agreement/correlations among different measures so the comment is correct that different units of measure are being assessed. The informant-completed questionnaire (modified clinical global impression of severity for informants (mCGI-S-INF) and the clinical-rater completed questionnaire, Positive and Negative Syndrome Scale - Excited Component (PEC) are the primary outcomes being assessed. The mCGI-S-INF is a single item with a 0 to 3 point scale with higher values indicating more severe agitation. The PEC is a five item questionnaire with 7-point response options, overall scores range from 5 to 35 with higher scores indicating more severe agitation.

Informant training materials assessment
Within 7 days of the intervention

Assess content validity of the Modified Clinical Global Impression of Severity for Informants (mCGI-S-INF) and informant training materials. The scale being utilized is mCGI-S-INF. There is no score as it is a qualitative assessment and it is being validated to measure patient informant reported outcomes against patient reported outcomes (mCGI-S-PAT) and physician reported outcomes using the Positive and Negative Syndrome Scale - Excited Component (PEC) scale where the highest score indicates the maximum agitation that could be experienced.

Secondary Endpoints
Patient and Clinician ratings comparison
Before and 2 hours after the intervention
Patient training materials assessment
Within 7 days of the intervention
Patients completion of the Modified Clinical Global Impression of Severity for Patients (mCGI-S-PAT)
Before and 2 hours after the intervention
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
BXCL501 Sublingual filmEXPERIMENTALExperimental: 120 mcg of BXCL501 Sublingual film containing 120 Micrograms Dexmedetomidine
Interventions
NameTypeDescription
BXCL501 Sublingual FilmDRUGSingle dose BXCL501 120 mcg
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria for Participant: 1. Male and female patients 18 to 75 years old, inclusive. 2. Patients who can read, understand, and provide written informed consent. 3. Patients who meet the Diagnostic and Statistical Manual of Mental Disorders, v5, Text Revision (DSM-5-TR) criteria for a prim...

Countries:United States
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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT07116694TRIAL_REMOVED: changed
LOWMay 24, 2026NCT07116694studyFirstPostDate: changed